The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 2)

Phase 4Not Yet RecruitingNCT07303868

Boston Children's Hospital66 enrolled

Overview

Using a four-week randomized, crossover study design, we will assess the impact of 2 weeks of a high bile acid-binding blenderized diet, compared to 2 weeks of a low bile acid-binding blenderized diet, on gastric and salivary bile acid concentrations within individual participants. Four weeks of an amino acid formula will be a comparator group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Feeding Difficulties Gastrostomy Aspiration

Interventions

Low bile acid binding blenderized dietDRUG

Low bile acid binding blenderized diet administered for 2 weeks

High bile acid binding blenderized dietDRUG

High bile acid binding blenderized diet administered for 2 weeks

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

Pediatric patients ages 5 to 21 in the randomized arm Inclusion criteria * receive at least 80% of their nutritional needs via gastrostomy * receive blenderized feeds or will start receiving blenderized feeds * have no known allergies to ingredients in blenderized feeds; * receive their bolus feeds within 30 minutes or less * can receive their feeds by syringe push Exclusion criteria * have undergone anti-reflux surgery * receive post-pyloric feeds * are allergic to any component of the administered diets * cannot receive their gastrostomy feeds over 30 minutes * require a feeding pump for feed administration (as the H-BBB is too thick for pump administration). Pediatric patients ages 5 to 21 in the observational arm Inclusion * receive at least 80% of their nutritional needs via gastrostomy * are taking an amino acid formula * have not undergone antireflux surgery Exclusion * have undergone anti-reflux surgery * receive post-pyloric feeds * are not receiving an amino acid-based formula.